MEDTEXX POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTA


Device Classification Name

latex patient examination glove

510(k) Number K991153
Device Name MEDTEXX POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTA
Applicant
MEDTEXX INDUSTRIES (THAI) CO. LTD.
200 mu-4, tambol tachang
po box 38 hatyai
amphur bangklam songkhla, 

TH

90110

Applicant Contact stephen tan ckeng kim
Correspondent
MEDTEXX INDUSTRIES (THAI) CO. LTD.
200 mu-4, tambol tachang
po box 38 hatyai
amphur bangklam songkhla, 

TH

90110

Correspodent Contact stephen tan ckeng kim
Regulation Number 880.6250
Classification Product Code
LYY  
Date Received 04/06/1999
Decision Date 06/21/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No